MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK E 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Synovitis (2094); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products:: cat# 00801803602 lot# 61827393 femoral head 12/14 taper.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 00265.0001822565 - 2023 - 00266.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent right total hip arthroplasty and was subsequently revised approximately twelve (12) years later due to metal related pathology and abductor tendon enthesopathy.During revision, synovitis, osteolysis, altr, and interstitial tearing/fraying of tendon were confirmed.The femoral head and neck were replaced, and the patient was also transitioned to a constrained liner without complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: office visit, patient-reported falling, distension of the hip joint synovitis, osteolysis, interstitial tearing, altr, tendon fraying.Approximately two months after office visit: altr, tendon enthesopathy, synovitis, fraying, tendon tear, black corrosion noted, no intra-op complications.Radiographically unremarkable appearance of the right total hip arthroplasty.If there is concern for soft tissue abnormality, mri with metal artifact reduction sequences would be the gold standard for evaluation.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further information at the time of this report.

• Brand Name: MODULAR NECK E 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16291561
• MDR Text Key: 308718872
• Report Number: 0001822565-2023-00202
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00784801200
• Device Lot Number: 61825594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 53 KG